Life Linc Patient Cable
FDA 510(k) K853452 · Tronomed, Inc.
510(k) numberK853452
Submission
- Device name
- Life Linc Patient Cable
- Applicant
- Tronomed, Inc.
Irvine, CA, US - Received
- August 16, 1985
- Decision date
- September 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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|---|---|---|
| K952659 | Tronomate Patient Cable & Leadwire SystemDSA · Traditional | 01/11/1996SE |
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| K841092 | High Pressure Flex. Connecting TubingDXT · Traditional | 07/24/1985SE |
| K792128 | Sterile Extension Tubes Indiv. Pkg.FMG · Traditional | 01/16/1980SE |
| K792127 | Plas. Stck. W/Extension Tube/SterileFMG · Traditional | 01/16/1980SE |
| K792126 | 3&4 Way Plastic Sterile Stpcks. Pkg.FMG · Traditional | 01/16/1980SE |
| K792125 | 3&4 Way Plastic Stopcocks, NonsterileFMG · Traditional | 01/16/1980SE |
| K792124 | Tandem Assembled 3&4 Way StopcocksFMG · Traditional | 01/16/1980SE |
| K771645 | Electrocardiographic Cablhs & Lead WireDSA · Traditional | 10/18/1977SE |
| K771027 | Electrocardiographic Patient CablesDSA · Traditional | 07/05/1977SE |
Questions and answers
When was Life Linc Patient Cable cleared by the FDA?
Life Linc Patient Cable (K853452) received a 510(k) decision of Substantially Equivalent on September 10, 1985, 25 days after the submission was received.
What is the product code of K853452?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.